# China NMPA Product Recall - defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/7630dec3-e8f4-41ef-937b-1f7d688e90d9/
Source feed: China

> China NMPA product recall for defibrillator by Philips Medical Systems published December 12, 2014. Recall level: Level II. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for specific defibrillato

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls defibrillators
- Company Name: Philips Medical Systems
- Publication Date: 2014-12-12
- Product Name: defibrillator
- Recall Level: Level II
- Recall Reason: When a Philips monitor-defibrillator is receiving an electrocardiogram (ECG) signal from an auxiliary bedside monitor via a synchronization cable, if the monitor-defibrillator is subjected to interference from electrical fast transient bursts (EFT) while connected to AC power, the following may occur: On HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as R waves. On HeartStart XL+, EFT noise may disable ECG monitoring and interrupt on-demand pacing*. *Note: This occurs due to a violation of the instructions in the XL+ Instruction User Manual (IFU) when performing on-demand pacing with an ECG signal from a bedside monitor using a synchronization cable. The XL+ IFU includes the following warning: "When pacing in on-demand mode, the ECG cable from the patient must be connected to the HeartStart XL+."
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for specific defibrillator models, including HeartStart MRx, HeartStart XL, and HeartStart XL+, as reported to the National Medical Products Administration (NMPA) and published on December 12, 2014. The recall stems from a reported issue where, under AC power and when connected to an auxiliary bedside monitor via a synchronization cable, the defibrillators may experience interference from electrical fast transient bursts (EFT). This interference can lead to critical malfunctions: on HeartStart MRx and HeartStart XL devices, EFT noise may be incorrectly interpreted as R-waves. For HeartStart XL+ units, EFT noise could disable ECG monitoring and interrupt on-demand pacing. While an existing instruction manual warning for the XL+ addresses a contributing factor, Philips is proactively addressing the broader risk. In response, Philips Medical Systems is implementing corrective actions by replacing the affected synchronization cables free of charge. Philips representatives are contacting users of the implicated devices to coordinate the cable replacement process, ensuring patient safety and device reliability in clinical settings.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47/